Pharmacovigilance

Pharmacovigilance

The unraveling of the human genome and the huge possibilities this, and other research, has opened to medicine points to a very healthy and robust growth in the decades ahead for the global pharmaceutical industry. Given the sensitive nature of this industry there is a growing and abundant need for regulation and control. This need emanates both from Public Health Administrators and from the Industry itself.

Pharmaceutical companies globally have, or are in the processing of implementing, an elaborate Pharmacovigilance system. The varied nature of regulations across different countries and regions and the complex nature of drug launch and performance require careful monitoring and analysis. This poses a unique challenge requiring specific skill sets and data management techniques.

Ajaxdotcom is a global healthcare service provider with 12 years experience in the industry. We  partner our clients in the pharmaceutical industry and provide Pharmacovigilance solutions.  We are a boutique firm, and focus sharply on our clients’ needs and specific requirements. Our strengths are the quality of our management and the flexibility we provide to our clients – adapting to their needs in a short time.

At Ajaxdotcom, our aim is to provide a time bound and high quality service to clients and help maintain good compliance. We offer services in ICSR processing and PSUR production. All personnel in our Pharmacovigilance division are well trained in various aspects of single case processing.

Our Leads have extensive and in-depth experience in EMEA and FDA regulations and we offer services in

ICSR processing
Expedited reporting
MedDRA coding
Legacy cases handling
Literature screening
AE call center
Periodic reports writing

We can modify and adapt established standard practices to your specific requirements. The Pharmacovigilance Division and its support systems are regularly audited as per our best and standard procedures audit. These are  open to client scrutiny on request.

ICSR processing:
ICSRs is the most important source of information for monitoring drug safety with the focus by authorities and current awareness among health care professionals and patient community, the ICSR reports are only going to increase in number. Managing these ICSRs round the year is a challenged faced today by most pharma companies.

Ajaxdotcom has extensive knowledge and experience in processing of ICSR including clinical and spontaneous case reports.

Clinical studies  ICSR:
We understand the fact that timely and accurate processing of the clinical trial SAE is imperative for success of the clinical trial. Currently all authorities requests SUSARs to be reported on an expedited basis, our effective tracking and alerting workflow mechanism will aid in maintaining regulatory compliance.

Spontaneous ICSR:
Spontaneous cases are not usually well documented and have to be analyzed and judged based on available information. We have safety physicians in-house who will make the correct decision keeping safety of the patient in mind. We also offer follow up of the respective stakeholders to obtain follow up information.

Our operation model ensures that ICSRs are processed on a timely manner and all reports are expedited within the regulatory time frames. We are flexible to the use of  proprietary software provided by the client. We can also cater to organizations that do not have their own software to database the ICSR.

AE call center:
Ajax has extensive experience in handling business calls and will leverage the same experience in managing calls from consumers regarding product information and adverse event notification.

Expedited reporting:
Our staff is well aware of drug safety regulations and are trained and prepared to make the correct judgment about expedited reporting. We can provide tailormade solutions for expedited reporting requirement.

Literature screening:
Screening literature articles to identify adverse events is mandated by both European and US regulations.  We can screen major publications to identify events associated with Client Company drugs and provide a concise narrative and also process the case in safety database.

Periodic reports writing:
Our staff is well trained and experienced in writing different sections of PSUR, PADER and other periodic reports. We can even write only specified sections as per requirement.